Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of Nottingham
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01047124
First received: January 11, 2010
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

The purpose of this study is determine whether a specialised mood disorder service, which offers tailored psychological and pharmacological treatment, is more effective in the treatment of chronic unipolar depressive disorder then treatment as usual.


Condition Intervention
Chronic Unipolar Depressive Disorder
Other: Specialist Mood Disorders Team

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Control Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale - Grid version [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in self rated depression measures: Beck Depression Inventory version 1; Personal Health Questionnaire; Quick Inventory of Depressive Symptomology [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Cost utility or cost effectiveness using the Euroqol 5D as a measure of quality of life and costs from health and social care and society perspectives. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in social adjustment (Cooper, Osborn, Gath & Feggetter, 1982), an assessment of social and occupational functioning. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient satisfaction and patient/doctor relationship [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 219
Study Start Date: September 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Specialist mood disorders team: treatment plan according to need
Other: Specialist Mood Disorders Team
The specialist mood disorders team will include a psychiatrist and health professionals providing cognitive behaviour therapy. Together the team will assess participants and then provide a co-ordinated and supervised combination of pharmacological and psychological treatment according to guidelines developed by NICE and the British Association of Psychopharmacology. Each participant will receive a treatment plan that is tailored to his/her specific needs.
Other Name: Collaborative care for depression
No Intervention: Treatment as usual

Detailed Description:

A pragmatic randomised controlled trial of a specialist mood disorder intervention versus treatment as usual will be conducted. Patients will be individually randomised with stratification by mental health trust to either treatment by a specialist team offering tailored psychological and pharmacological treatment or treatment as usual.

The specialist mood disorders team will include a psychiatrist and health professionals providing cognitive behaviour therapy. Together the team will assess participants and then provide a co-ordinated and supervised combination of pharmacological and psychological treatment according to guidelines developed by NICE and the British Association of Psychopharmacology. Each participant will receive a treatment plan that is tailored to his/her specific needs. The participants in the treatment as usual team will have their usual access to the same treatments. The outcome in terms of improvement in depressive symptoms, function and costs will be examined after one year in service users with chronic depression.

Eligible patients will be followed for 12 months and the primary outcomes will be observer rated depressive symptoms and cost effectiveness from a health and social care perspective. Along side the RCT, implementation analysis and audit of the standard care and specialised care for depression will be carried out.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The responsible medical officer or care coordinator leading care considers the patient to be suffering from a primary unipolar depressive disorder which is not a consequence of having another axis 1 or 2 psychiatric disorder.
  • Age over 18 years.
  • Able and willing to give oral and written informed consent to participation in the study.
  • From the date of first assessment by a health professional working for the index mental health trust, they have been offered or received direct care from one or more health professionals from the Trust three or more occasions for 6 months.
  • Meet NICE criteria for moderate depression, namely the presence of five out of nine symptoms of (NICE, 2004), have a Hamilton Depression Rating Scale of at least 20, and score 60 or less on the Global Assessment of Functioning Scale (American Psychiatric Association, 1994).

Exclusion Criteria:

  • Is receiving emergency care for suicide risk, risk of severe neglect or homicide risk and requires it; however, patients will not be excluded because of such risk provided the risk is adequately contained with their current care setting and the primary medical responsibility for care remains with the referring team.
  • Does not speak fluent English.
  • Is pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047124

Contacts
Contact: Sarah E Marttunen, MSc +44(0)1158232478 sarah.marttunen@nottingham.ac.uk
Contact: Richard Morriss +44(0)115820427 richard.morriss@nottingham.ac.uk

Locations
United Kingdom
Derbyshire Mental Health NHS Trust Not yet recruiting
Derby, Derbyshire, United Kingdom
Contact: Marttunen    +44(0)1158232478      
Principal Investigator: Paul Gilbert, MSc, PhD, Dip Clin Psyc, FBPsS         
Lincolnshire Partnership Trust Not yet recruiting
Lincoln, Lincolnshire, United Kingdom
Contact: Marttunen    +44(0)1158232478      
Principal Investigator: Simon Loosmore, MB ChB, MRCpsych         
Nottinghamshire Healthcare NHS Trust Recruiting
Nottingham, Nottinghamshire, United Kingdom
Contact: Marttunen    +44(0)1158232478      
Principal Investigator: Richard Morriss, MBChB, MRCpsych, MMedSci, MD         
Sponsors and Collaborators
University of Nottingham
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Richard Morriss University of Nottingham
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01047124     History of Changes
Other Study ID Numbers: 09044
Study First Received: January 11, 2010
Last Updated: October 4, 2012
Health Authority: United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
Depression
Collaborative Care
Cognitive Behaviour Therapy
Mental Health Services
Antidepressants

Additional relevant MeSH terms:
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 28, 2014